Systemic Metabolic Rate of Diabetic Patients Before and After Bariatric Gastric Bypass Using the Breezing® Device.

Kaiser Clinic and Hospital

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT05505773

Breezing

Details and patient eligibility

About

To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Full description

Objective of the research:

Primary To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Secondary

• To measure the indirect metabolic rate by quantifying O2 gas consumption (g) and CO2 gas release (g);
• To analyze the 'population impact', that is, to measure using statistical tools how many cases of metabolic maladjustment could be prevented if the diabetes risk factor were to be eliminated;
• To correlate, by means of a regression test, if there is any dependence between the metabolic rate and the diabetes risk factor;
• To validate the accuracy of the Breezing® device.

Evaluation of the risks and benefits Risks As the patient only needs to blow on the Breezing® device using a small straw (blower), the direct risks are minimal, perhaps contamination due to failure to exchange the blower. Thus, the risks are indirect and are more associated to the malfunctioning of the device.

Benefits The advantage is that the procedure is simple and can provide results with important information about the metabolic rate even just using the iPhone or iPad of patients as a strategy to monitor metabolic control.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: over 18 years -

Exclusion Criteria: obesity